206. 脆弱Ｘ症候群 Fragile X syndrome Clinical trials / Disease details
臨床試験数 : 104 / 薬物数 : 87 - (DrugBank : 32) / 標的遺伝子数 : 54 - 標的パスウェイ数 : 79
| No. | TrialID | Date_ enrollment | Date_ registration | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 1 | EUCTR2011-002379-40-BE (EUCTR) | 02/12/2013 | 24/10/2013 | Long-term, safety and tolerability study of AFQ056 in adolescent patients with Fragile X Syndrome (Open–label) | An open-label study to evaluate the long-term safety and tolerability of AFQ056 in adolescent patients with Fragile X Syndrome | Fragile X syndrome MedDRA version: 14.1;Level: PT;Classification code 10017324;Term: Fragile X syndrome;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: AFQ056 Product Code: AFQ056 INN or Proposed INN: Mavoglurant Product Name: AFQ056 Product Code: AFQ056 INN or Proposed INN: Mavoglurant | Novartis Pharma Services AG | NULL | Not Recruiting | Female: yes Male: yes | 180 | Phase 2 | United States;Spain;Indonesia;Turkey;Israel;United Kingdom;Switzerland;Italy;France;Canada;Belgium;Brazil;Australia;Denmark;Germany;Netherlands;Sweden | ||
| 2 | EUCTR2010-022638-96-NL (EUCTR) | 08/07/2013 | 08/05/2013 | Safety and efficacy of AFQ056 in adolescent patients with Fragile X Syndrome | A randomized, double-blind, placebo-controlled, parallel group study to evaluate the efficacy and safety of AFQ056 in adolescent patients with Fragile X Syndrome | Fragile X Syndrome MedDRA version: 16.0;Level: PT;Classification code 10017324;Term: Fragile X syndrome;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: AFQ056 Product Code: AFQ056 INN or Proposed INN: mavoglurant Product Name: AFQ056 Product Code: AFQ056 INN or Proposed INN: mavoglurant | Novartis Pharma Services AG | NULL | Not Recruiting | Female: yes Male: yes | 120 | United States;Spain;Indonesia;Turkey;Israel;Italy;Switzerland;United Kingdom;France;Canada;Brazil;Australia;Denmark;Netherlands;Germany;Sweden | |||
| 3 | EUCTR2011-002379-40-NL (EUCTR) | 08/07/2013 | 08/05/2013 | Long-term, safety and tolerability study of AFQ056 in adolescent patients with Fragile X Syndrome (Open–label) | An open-label study to evaluate the long-term safety and tolerability of AFQ056 in adolescent patients with Fragile X Syndrome | Fragile X syndrome MedDRA version: 16.0;Level: PT;Classification code 10017324;Term: Fragile X syndrome;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: AFQ056 Product Code: AFQ056 INN or Proposed INN: Mavoglurant Product Name: AFQ056 Product Code: AFQ056 INN or Proposed INN: Mavoglurant | Novartis Pharma Services AG | NULL | Not Recruiting | Female: yes Male: yes | 180 | United States;Spain;Indonesia;Turkey;Israel;Italy;Switzerland;United Kingdom;France;Canada;Brazil;Australia;Denmark;Netherlands;Germany;Sweden | |||
| 4 | EUCTR2010-022638-96-BE (EUCTR) | 27/05/2013 | 18/04/2013 | Safety and efficacy of AFQ056 in adolescent patients with Fragile X Syndrome | A randomized, double-blind, placebo-controlled, parallel group study to evaluate the efficacy and safety ofAFQ056 in adolescent patients with Fragile X Syndrome | Fragile X Syndrome MedDRA version: 14.1;Level: PT;Classification code 10017324;Term: Fragile X syndrome;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: AFQ056 Product Code: AFQ056 INN or Proposed INN: Mavoglurant Product Name: AFQ056 Product Code: AFQ056 INN or Proposed INN: Mavoglurant | Novartis Pharma Services AG | NULL | Not Recruiting | Female: yes Male: yes | 120 | Phase 2 | United States;Spain;Indonesia;Turkey;Israel;Italy;Switzerland;United Kingdom;France;Canada;Belgium;Brazil;Australia;Denmark;Netherlands;Germany;Sweden | ||
| 5 | EUCTR2010-019353-18-Outside-EU/EEA (EUCTR) | 31/10/2011 | Two-period, single-dose pharmacokinetic study in male adolescent patients with Fragile X Syndrome (FXS). | A sequential, open-label, two-period study to assess the pharmacokinetics, safety and tolerability of two dose levels of AFQ056 in male, adolescent patients with Fragile X Syndrome (12 to 18 years inclusive) | Fragile X Syndrome MedDRA version: 14.0;Level: PT;Classification code 10017324;Term: Fragile X syndrome;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: AFQ056 Product Code: AFQ056 INN or Proposed INN: mavoglurant Product Name: AFQ056 Product Code: AFQ056 INN or Proposed INN: mavoglurant | Novartis Pharma Services AG | NULL | NA | Female: no Male: yes | 12 | Switzerland | ||||
| 6 | EUCTR2010-022638-96-Outside-EU/EEA (EUCTR) | 31/10/2011 | Safety and Efficacy of AFQ056 in Adolescent Patients With Fragile X Syndrome | A randomized, double-blind, placebo-controlled, parallel group study to evaluate the efficacy and safety of AFQ056 in adolescent patients with Fragile X Syndrome - | Fragile X Syndrome MedDRA version: 14.0;Level: PT;Classification code 10017324;Term: Fragile X syndrome;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: AFQ056 Product Code: AFQ056 INN or Proposed INN: mavoglurant Product Name: AFQ056 Product Code: AFQ056 INN or Proposed INN: mavoglurant | Novartis Pharma Services AG | NULL | NA | Female: yes Male: yes | 160 | Australia;United States |